Tobramycin Solution

Tobramycin Solution is used for:

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Treating cystic fibrosis patients with certain infections (Pseudomonas aeruginosa. It may also be used for other conditions as determined by your doctor.

Tobramycin Solution is an aminoglycoside antibiotic. It works by killing sensitive bacteria.

Do NOT use Tobramycin Solution if:

• you are allergic to any ingredient in Tobramycin Solution or another aminoglycoside antibiotic (eg, gentamicin)
• you are taking loop diuretics (eg, furosemide, ethacrynic acid), cyclosporine, mannitol, methoxyflurane, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or urea

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tobramycin Solution:

Some medical conditions may interact with Tobramycin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed) or Parkinson disease
• if you have hearing problems, nerve problems, kidney problems, or severe or extensive burns, or you are dehydrated

Some MEDICINES MAY INTERACT with Tobramycin Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, gentamicin), cephaloridine, cephalosporins (eg, ceftizoxime), cisplatin, colistin, cyclosporine, fludarabine, loop diuretics (eg, furosemide, ethacrynic acid), mannitol, methoxyflurane, nitrosoureas (eg, carmustine), NSAIDs (eg, ibuprofen), polymyxin B, urea, vancomycin, or viomycin because they may increase the risk of Tobramycin Solution's side effects, including increased risk of kidney or hearing loss
• Nondepolarizing muscle relaxants (eg, atracurium) or succinylcholine because the risk of their side effects may be increased by Tobramycin Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tobramycin Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tobramycin Solution:

Use Tobramycin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Tobramycin Solution. Talk to your pharmacist if you have questions about this information. Read it carefully for instructions on how to prepare Tobramycin Solution for inhalation, administer it, clean and disinfect your nebulizer, and care for your Pulmo-Aide Compressor. Talk to your pharmacist if you have questions about this information.
• If you are also using dornase alfa, do not mix Tobramycin Solution in the same nebulizer as the dornase alfa.
• If you are taking several inhaled medicines, talk to your doctor about the best order for taking your medicines.
• Tobramycin Solution is normally slightly yellow in color and may darken with age if it has been left out of the refrigerator. This will not change the effectiveness of Tobramycin Solution.
• Do not use Tobramycin Solution if it is cloudy, contains particles, or if it has been stored at room temperature for more than 28 days.
• Tobramycin Solution is usually used in cycles of 28 days on the medicine followed by 28 days off the medicine. Follow the dosing schedule given to you by your doctor carefully.
• Use your doses as close to 12 hours apart as possible.
• If you miss a dose of Tobramycin Solution, use it as soon as possible. If it is less than 6 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tobramycin Solution.

Important safety information:

• Tobramycin Solution only works against bacteria; it does not treat viral infections (eg, the common cold).
• Drinking extra fluids while you are using Tobramycin Solution is recommended. Check with your doctor for instructions.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Be sure to use Tobramycin Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Tobramycin Solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Tell your doctor or dentist that you take Tobramycin Solution before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including kidney function, hearing tests, and tobramycin levels, may be performed while you use Tobramycin Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Tobramycin Solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tobramycin Solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobramycin Solution while you are pregnant. It is not known if Tobramycin Solution is found in breast milk after inhalation. Do not breast-feed while taking Tobramycin Solution.

Possible side effects of Tobramycin Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Discolored sputum; voice changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; clumsiness; confusion; decreased hearing; decreased urination; dizziness or lightheadedness; feeling of a whirling motion; fever, chills, or persistent sore throat; hearing loss; loss of coordination; muscle weakness; numbness or tingling; ringing or roaring in the ears; seizures; severe or persistent diarrhea; shortness of breath; stomach pain or cramps; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; difficulty moving the arms or legs; dizziness; hearing loss; ringing in the ears; trouble breathing; unsteadiness.

Store Tobramycin Solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Tobramycin Solution may be stored in the foil pouches at room temperature below 77 degrees F (25 degrees C) for up to 28 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tobramycin Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Tobramycin Solution, please talk with your doctor, pharmacist, or other health care provider.
• Tobramycin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tobramycin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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